BEUDAMED
    FDA Enforcement Class III Ongoing

    a. INTEGRA LIFESCIENCE (WND CARE) Shur-Conform Oil Emulsion Oil Emulsion Impregnated Dressing Shur-Conform 3 X 8 Inch Knitted Cellulose Acetate Petrolatum Emulsion Sterile Model Number: 77042. b. INTEGRA LIFESCIENCE (WND CARE) ALGICELL Ag Silver Alginate Dressing Algicell Ag 4 X 5 Inch Rectangle Sterile Model Number: DUP88545

    Recall: Z-1800-2022 · Reported October 5, 2022

    Enforcement

    Recall Number
    Z-1800-2022
    Event ID
    90731
    Classification
    Class III
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Mckesson Medical-Surgical Inc. Corporate Office
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    October 5, 2022
    Initiation Date
    May 25, 2022
    Classification Date
    September 26, 2022
    Address
    9954 Maryland Drive, Deep Run Iii Ste. 4000, Richmond, VA, 23233, United States

    Description

    a. INTEGRA LIFESCIENCE (WND CARE) Shur-Conform Oil Emulsion Oil Emulsion Impregnated Dressing Shur-Conform 3 X 8 Inch Knitted Cellulose Acetate Petrolatum Emulsion Sterile Model Number: 77042. b. INTEGRA LIFESCIENCE (WND CARE) ALGICELL Ag Silver Alginate Dressing Algicell Ag 4 X 5 Inch Rectangle Sterile Model Number: DUP88545

    Reason

    Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21. This device with this specific storage temperature deviation is not likely to cause adverse health consequences.

    Code Info

    GTIN: a. 10381780491781 EA; 30381780491785 CS. b. 10381780491675 EA; 30381780491679 CS

    Distribution

    US Nationwide distribution.

    Quantity

    a. 6 bx b. 308 cs.